In practice, the reimbursement of medical devices reported as separately charged materials (ZUM) is governed by the rules established by the General Health Insurance Company of the Czech Republic (VZP ČR) in its Methodology for the Inclusion, Changes and Increases in the Price and Reimbursement of Medical Devices Reimbursed from Public Health Insurance as ZUM within the VZP Medical Devices Reimbursement Catalogue.
The Methodology sets out the procedures for including new ZUM in the VZP Medical Devices Reimbursement Catalogue, making changes to devices already included in the Catalogue, and increasing their price and reimbursement.
A new version 3.0 takes effect on 1 September 2026, introducing a major change in the assessment of innovative ZUM.
The previous distinction between moderate and substantial innovation has been replaced by three pathways: medical device innovation bonus, expert assessment of innovation, and economic and clinical assessment (HTA).
📈 Medical Device Innovation Bonus
A simplified pathway for ZUM where the clinical benefit can be demonstrated by meeting predefined clinical criteria. If at least one of these criteria is met, a 15% bonus may be granted compared with the reference comparator or group of reference comparators. The criteria include, for example, improvement in a clinically relevant outcome, shorter hospitalisation or recovery time, or a reduced risk of reoperation or reimplantation.
🔎 Expert Assessment of Innovation
This pathway is intended for ZUM providing a relevant clinical, safety or organisational benefit where a full economic and clinical assessment is not required. The assessment focuses in particular on clinical effectiveness, safety, quality of evidence, organisational benefits, implementation requirements, and the expected budget impact. A budget impact analysis (BIA) must be included in the submission.
📊 Economic and Clinical Assessment (HTA)
The most comprehensive pathway applies to innovative ZUM with a significant impact on the public health insurance system or where it is necessary to assess whether the additional costs are proportionate to the claimed clinical benefit. The assessment covers clinical benefits, safety, cost-effectiveness and budget impact. This pathway is also subject to the VZP ČR Methodology for the Economic and Clinical Assessment of Medical Devices.
The Methodology also addresses, among other matters, maximum assessment timelines for selected procedures, the possibility of increasing prices and reimbursement in accordance with the applicable Price Regulation, and the possibility of suspending the assessment process in order to obtain expert opinions.
Do you need assistance with preparing the documentation for the establishment of the price and reimbursement of your medical device by VZP? Do not hesitate to contact us.
Pharmeca a.s. has extensive experience, including in the field of economic and clinical assessment (HTA). This expertise enables us to support you in preparing a complete documentation package for the assessment of your medical device.
Our knowledge, your opportunity.
The English translation was prepared using the latest available ChatGPT model.